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RECRUITING
NCT04402242
NA

Impact of NOL Index Intraoperative Guided Remifentanil Analgesia

Sponsor: Hopital Foch

View on ClinicalTrials.gov

Summary

The Physiological Monitoring Device (PMD-200™) system is comprised of a monitor and a designated finger probe containing 4 sensors. The sensors included are Photoplethysmography (PPG), Galvanic Skin Response (GSR), Accelerometer for movement (ACC) and Thermistor for peripheral temperature (TMP). The PMD-200 is intended to be used for assessing the nociception level in anesthetized patients. The purpose of the study is confirmation of a reduction in the dosage of remifentanil allowed by the monitoring of nociception by the NOL which could open the way to a double control of the administration of anesthetic agents: control of the administration of hypnotics by the bispectral index (BIS) and control of the administration of opiate by the NOL.

Official title: Impact of Nociceptive-Level (NOL) Intraoperative Guided Remifentanil Analgesia Versus Standard Clinical Care (SCC) for Elective Major Abdominal Surgery

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

210

Start Date

2021-04-13

Completion Date

2025-05

Last Updated

2024-06-14

Healthy Volunteers

No

Interventions

DEVICE

Bispectral index

Anesthesia monitoring

DEVICE

Bispectral index + NOL index

Anesthesia monitoring

Locations (3)

Hôpital d'Instruction des Armées - Sainte-Anne

Toulon, Provence-Alpes-Côte d'Azur Region, France

Hopital d'Instruction des Armées de Bégin

Saint-Mandé, Saint Mandé, France

Foch Hospital

Suresnes, France